Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

This study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (SLE) and to confirm the optimal dose of atacicept for treatment of subjects with SLE and gain information on the effect of atacicept on markers specific to its mechanism of action (MoA) and their correlation to disease activity/progression. Study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. Following the last treatment, a safety follow-up period of 24 weeks will be conducted.

Key facts

Study ID

NCT00624338

Run by

EMD Serono

People needed

461

Starts

2008-01-01

Expected to finish

2012-10-01

Last updated by the study team

2016-03-14

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 16 years of age or older
• Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
• Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
• Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
• Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
• Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
• Previous treatment with rituximab, abatacept, or belimumab
• History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
• Other protocol defined exclusion criteria could apply

Where it is running

• Stanford University — Palo Alto, California, United States
• Research Site — San Diego, California, United States
• Inland Rheumatology Clinical Trials Inc — Upland, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Boise, Idaho, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• US Local Medical Information — Rockland, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Justus J. Fiechtner, MD, MPH — Lansing, Michigan, United States
• SUNY Health Science Center at Brooklyn — Brooklyn, New York, United States
• Feinstein Institute for Medical Research — Manhasset, New York, United States
• Hospital for Special Surgey — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Cincinnati, Ohio, United States
• University of Cincinnati Medical Center, Division of Immunology — Cincinnati, Ohio, United States
• Research Site — Temple, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Research Site — Buenos Aires, Argentina
• Research Site — Córdoba, Argentina
• Research Site — Quilmes, Argentina
• Research Site — San Juan, Argentina
• Research Site — San Miguel de Tucumán, Argentina
• Research Site — Cairns, Australia
• Research Site — Clayton, Victoria, Australia
• Division of Clinical Immunology and Rheumatology - UAB — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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